NCT04729933

Implantation of a Permanent Interatrial Shunt to Reduce Left Atrial Filling Pressures Following MitraClip

Implantation of a Permanent Interatrial Shunt to Reduce Left Atrial Filling Pressures Following MitraClip: The V-Wave Shunt MitraClip Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: samir kapadia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an investigator initiated, prospective study to demonstrate the safety and feasibility of implantation of the V-Wave Interatrial Shunt System (herein called the "V-Wave Shunt" in patients immediately following percutaneous mitral valve repair using the MitraClip system.

Detailed description

The V-Wave Shunt is a device placed across the interatrial septum (IAS) by cardiac catheterization which allows for the transfer of blood from the left atrium (LA) to right atrium (RA). The intended effect is to reduce excessive left-sided cardiac filling pressures in patients with advanced heart failure (HF) and thus improve symptoms related to pulmonary congestion. All patients in the study must meet all anatomic and clinical eligibility in the FDA approved indications for use of the MitraClip in functional mitral regurgitation (MR). All patients must have persistence of New York Heart Association (NYHA) class III or ambulatory class IV HF symptoms despite maximally tolerated guideline directed medical therapy (GDMT) as assessed by a Cardiologist specialist in advanced heart failure (HF). All patients will have reduced left ventricular (LV) ejection fraction (EF) ≥ 20% and ≤ 50% and at least moderate to severe 3-4+ MR with a functional or combined functional and degenerative mechanism. Despite MitraClip treatment and maximum GDMT, these patients are at high risk for recurrent HF events and readmission, and thus there is an unmet need for further therapies to improve outcomes in this patient population. The existing transseptal puncture used for MitraClip placement will be used to place the V-Wave Shunt device after MitraClip placement.

Conditions

• Heart Failure
• Mitral Regurgitation

Interventions

Type	Name	Description
DEVICE	V-Wave Shunt Placement	After the MitraClip Placement and after final screening, the existing transseptal puncture used for MitraClip placement is used to place the V-WAVE Shunt device.

Timeline

• Start date: 2021-03-11
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2021-01-29
• Last updated: 2025-05-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study